What side effects are associated with this type of intervention?

Common treatments for motion sickness, such as intranasal scopolamine, often aim to enhance absorption through the nasal mucosa. The side effects of these treatments can include dry mouth, drowsiness, dizziness, and blurred vision. Intranasal administration may also cause nasal irritation or discomfort. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment option.

What prior FDA approvals exist?

The FDA has approved several treatments for motion sickness, including oral medications like dimenhydrinate (Dramamine) and meclizine (Antivert), as well as transdermal scopolamine patches. These treatments primarily work by blocking histamine or acetylcholine receptors to prevent nausea and vomiting. While intranasal delivery methods are being studied for enhanced absorption through the nasal mucosa, there are no specific FDA-approved intranasal treatments for motion sickness currently available. The ongoing research aims to improve the efficacy and onset of action for anti-motion sickness medications through this novel delivery route.

What other types of research exist?

Promising novel alternatives to intranasal nebulizers for motion sickness treatment in 2024 include transdermal patches, such as scopolamine patches, which provide continuous drug delivery and are convenient for patients. Additionally, oral dissolvable films and sublingual tablets are emerging as effective options due to their rapid onset of action and ease of use. These methods enhance drug absorption and improve patient compliance.

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Nebulized Scopolamine for Motion Sickness

Phase 1

Recruiting

Led By Jay C Buckey, Ph.D

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal weight for body size, based on BMI table

Renal and hepatic function within normal ranges

Must not have

Drug allergies to scopolamine or other belladonna alkaloid

Significant deviated septum that blocks air flow in one nostril

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 minutes

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial is testing a new way to give anti-motion sickness medicine by spraying it into the nose. It targets people who get motion sickness and aims to provide faster relief by allowing quick absorption through the nasal tissues.

Who is the study for?

Adults aged 21-49 in good health, with normal weight and organ function, can join this trial. They must not have used investigational drugs recently, smoked tobacco within a year, or lost significant blood lately. Pregnant women and those on certain medications or with specific medical conditions like respiratory issues or drug allergies are excluded.

What is being tested?

The study is testing the effectiveness of delivering Scopolamine through an intranasal nebulizer to prevent motion sickness compared to a placebo (a treatment with no active drug). Participants will receive either the real medication or placebo without knowing which one they're getting.

What are the potential side effects?

Scopolamine may cause dry mouth, dizziness, blurred vision, and drowsiness. Less common side effects include confusion and difficulty urinating. The placebo is unlikely to cause any side effects since it doesn't contain an active drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My weight is normal for my height.

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My kidney and liver functions are normal.

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I am between 21 and 49 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to scopolamine or similar medications.

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I have a severe blockage in one nostril due to a deviated septum.

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I am unable to give consent by myself.

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I am currently using nasal spray medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale

Time to maximal concentration for scopolamine after intranasal administration (Tmax)

Secondary study objectives

Effectiveness in reducing motion sickness as measured by duration of chair ride.

Side effects data

From 2014 Phase 1 trial • 27 Patients • NCT02051335

13%

Nausea

13%

Vision blurred

13%

Dizziness

Dry mouth

Oropharyngeal pain

100%

80%

60%

40%

20%

Study treatment Arm

A: Placebo

B: Donepezil 10 mg

C: Roflumilast Dose A

D: Roflumilast Dose A + Donepezil 10 mg

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PharmacokineticExperimental Treatment1 Intervention

Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC.

Group II: ChairExperimental Treatment2 Interventions

Participants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Scopolamine

FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for motion sickness often involve antihistamines and anticholinergics. Antihistamines, such as dimenhydrinate and meclizine, work by blocking histamine receptors in the brain that are involved in the vomiting reflex. Anticholinergics, like scopolamine, inhibit the action of acetylcholine, a neurotransmitter that can trigger nausea and vomiting. The intranasal delivery method, as studied with intranasal nebulizers, enhances absorption through the nasal mucosa, providing faster onset of action and potentially more effective symptom relief. This is particularly important for motion sickness patients who need quick and efficient relief to continue their activities without discomfort.

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